FDA UDI
In Commercial Distribution
🇺🇸 United States
Anti-H. pylori IgG
DI: 00845533002479
·
Model: 3Z51021G
·
ZEUS SCIENTIFIC, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Anti-H. pylori IgG
- Primary DI
- 00845533002479
- Version / Model
- 3Z51021G
- Catalog Number
- 3Z51021G
- Company Name
- ZEUS SCIENTIFIC, INC.
- Labeler DUNS
- 080953946
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-17
- Public Version
- 1
- Public Version Date
- 2025-12-25
- Public Version Status
- New
- Public Device Record Key
- c19bd885-c5e8-4035-9d40-9fef7c07ad8e
Device Description
The Anti Helicobacter pylori IgG is an enzyme-linked immunosorbent assay for the qualitative detection of IgG antibodies to H. pylori in sera from symptomatic adults. This device is for In Vitro diagnostic use.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 51008 | Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Helicobacter pylori bacteria in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00845533002479 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius